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OpenTrials
Completed

NCT Number: NCT00585702

Antimanic Drug Use in Pregnancy

The purpose of this study is to learn about the effects of bipolar disorder or the use of antimanic medications on the mother's health and wellbeing during pregnancy and for the first postpartum year. Infant health and development are also assessed during the first year. Participation in the study includes 7 study visits, three in pregnancy and four postpartum.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Bipolar Subjects:

  • Age 18 or older
  • Pregnant at 20 weeks or more
  • Women must receive OB care
  • English-speaking
  • DSM-IV diagnosis of BP, any subtype

Inclusion criteria

for non-Bipolar Control Subject:

  • Age 18 or older
  • Pregnant at 20 weeks or more
  • English-speaking
  • Women must receive OB care.
  • Women may have past or present subclinical Major Depressive Disorder according to the DSM-IV.

Exclusion criteria

for all:

  • Women must have no Active Alcohol Abuse or Dependence, Active Abuse or Dependence of Opiates, Inhalants, Amphetamines including Ecstasy or LSD, Active IV Drug Abuse, or Methadone Maintenance.
  • Women must not take drugs in the FDA categories D or X.

Additional Exclusion Criteria for Control Subjects:

  • Women must have no lifetime history of Bipolar Disorder or antimanic drug use.

Treatment and study plan

Primary outcomes

  1. SIGH-ADS

    Time frame: 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum

  2. Mania Rating Scale

    Time frame: 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum

  3. Bayley Scales of Infant Development

    Time frame: 12, 28, 52 weeks postpartum

Secondary outcomes

  1. Weight gain in pregnancy

    Time frame: 20,30,36 weeks gestation

  2. Structured Clinical Interview for DSM-IV

    Time frame: 20 weeks gestation at enrollment

  3. Nutritional Blood Levels

    Time frame: 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum

  4. Maternal Functioning and Gratification

    Time frame: 2, 12, 28, 52 weeks postpartum

  5. Infant physical exam

    Time frame: 2,12,28,52 weeks post delivery

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: AMUP

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Jan 3, 2008
Registry last updated
Oct 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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